Stanbio Recalls RaPET RF Latex Reagent Due to False Positive Test Results
Stanbio Laboratory is recalling RaPET RF Latex Reagent because it causes all patient serum samples to yield weakly positive test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that leads to inaccurate diagnostic results (false positives), which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Stanbio Laboratory, LP is recalling 686 units of RaPET RF Latex Reagent, Lot 21675. This reagent is used as a component in RaPET RF kits intended for the qualitative and semiquantitative detection of rheumatoid factor in human serum. The affected kits include RaPET RF (1155-100), RF Latex (1156-001), and RF Latex (1155L-100B) with specific control numbers and expiry dates ranging from April 2019 to December 2019.
The recall was initiated because the defective reagent causes all patient serum samples to yield a weakly positive test result. This defect compromises the accuracy of the latex slide test, which is intended to be used as an aid in the diagnosis of rheumatoid arthritis.
The affected products were distributed worldwide, including the United States, Canada, Korea, Mexico, and Trinidad. Healthcare facilities and laboratories that have used or possess this specific lot of reagent should stop using it and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) P
- Manufacturer
- Stanbio Laboratory, LP
- Affected units
- 686
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 21675
Distribution
Distributed nationwide across the United States.
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